BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2966654 · Received February 18, 2013

    Report

    Report Number
    3004209178-2013-02800
    Event Type
    Injury
    Date Received
    February 18, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V813549, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHOCKING OR JOLTING SENSATION OCCURRED FOLLOWING A FALL ON (B)(6) 2013. WHEN THE PATIENT FELL, SHE LANDED DIRECTLY ON HER IMPLANT. IT WAS STATED THAT THE DEVICE WAS NOW "BACKFIRING" ON HER - A SHOCK THAT WAS DESCRIBED AS "UNREAL." IT WAS ALSO STATED THAT THE DEVICE HAD MOVED. THE DEVICE HAD WORKED GREAT, THE PATIENT WENT FROM "GOING 70 TIMES A DAY TO 20 OR 30." IT WORKED WELL UNTIL SHE FELL ON THE DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM AND SHE BROUGHT PROGRAMMER WITH HER. THE DOCTORS THERE COULDN'T TURN DEVICE OFF. PATIENT'S DEVICE WAS AT 0.0 V AND THE PATIENT WAS STILL BEING SHOCKED. THE PATIENT WAS GIVEN A UROLOGIST CONTACT INFORMATION THAT SHE COULD GO TO. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS STATED THE PATIENT WANTED HER DEVICE REMOVED BUT NO ONE WILL REMOVE IT FOR HER. FOLLOWING A FALL IN (B)(6) 2013 SHE HAD NUMEROUS ISSUES. IT WAS STATED THE PATIENT WAS FRUSTRATED AND THOUGHT SHE WAS GOING TO HAVE A NERVOUS BREAKDOWN. REPORTEDLY, THE PATIENT WAS HURTING SO BAD IT WAS ¿UNREAL¿ AND WAS GETTING SHOCKED OFF AND ON FROM THE DEVICE WHICH CAN¿T BE TURNED OFF. THE PAIN BEGAN IN (B)(6) 2013 AND BECAME MORE INTENSE SINCE THE END OF (B)(6) 2013. TWO DAYS PRIOR TO REPORT THE PAIN WAS SPREADING AND HURTING HER SPINE AREA ON HER LEFT SIDE AND SPREADING TO HER RIGHT SIDE/HIP AREA.

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD BEEN DISCHARGED FROM THE PHYSICIAN'S PRACTICE AND NO OTHER INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS ABLE TO CONNECT WITH THE PATIENT AND DISCUSSED HER CURRENT NEED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. THE PATIENT WAS REFERRED TO A SURGEON THAT TAKES MEDICAID AND THE PATIENT WAS SCHEDULED FOR A CONSULT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS "GOING HAYWIRE." IT WAS STATED THAT THE PATIENT WAS STILL HAVING ISSUES WITH THE DEVICE, AND WANTED THE DEVICE EXPLANTED. IT WAS STATED THAT THE PATIENT "ALREADY MADE SEVERAL TRIP" TO THE EMERGENCY ROOM AND FELT THAT SHE NEEDED TO GO AGAIN ON THE NIGHT OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70477 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention